PROCESS AND SYSTEM FOR THE CUSTOMIZED PRODUCTION OF SKIN PATCHES

Description

FIELD OF THE INVENTION

The invention relates to the industrial field of the customized production of skin patches.

PRIOR ART

The term alopecia indicates the process of diminishing the quality (color, thickness) and quantity of hair or its disappearance.

Male pattern baldness is certainly the most common and is characterized by a recession of the hair, which affects the sides of the forehead and/or the upper part of the head; if the hair loss continues, the two areas eventually meet leaving only a line of hair on the lower back of the head. In Italy, men who have a hair loss problem are 39.01%, with an increasing percentage with increasing age.

It's not just men who have baldness problems. Female alopecia is much more widespread today than in the past and affects 4 million women in Italy, about 13% of the female population (statistics provided by the Helvetico Sanders Institute Tricological Center, which has been operating in the sector for over 30 years).

This problem brings with it many psychological and social inconveniences, much more than in the case of men: a woman who loses a massive amount of hair often does not want to cut her hair drastically and it is difficult to mask the baldness.

To remedy the hair loss resort was made to the use of wigs or hair transplantation. Hair transplantation consists of a real surgery that usually shows its results after months. For example, U.S. Pat. No. 5,782,851A claims a system for transplanting hair grafts from a donor region of a patient's scalp to a recipient region of a patient's scalp. The system includes harvesting a specified number of skin strips containing live hair follicles from the donor region of the patient's scalp and then cutting the skin strips into hair grafts. Implantation includes implanting the hair grafts into the recipient region of the patient's scalp, one at a time. This system is particularly long and invasive, as well as extremely expensive.

The traditional self-transplant instead, by moving the patient's hair from one area of the skin to the one most affected by baldness, cannot thicken because it moves some hair leaving new areas without hair.

Skin patches consist of an ultra-thin and invisible base (of different materials) where (natural or synthetic) hair is knotted which is applied to the skin in areas where there is no hair, faithfully simulating hair. They have the advantage of not requiring any type of surgical operation.

The skin patch can be considered a “modern” wig, the result of evolution, studies and innovations in the field of trichology that deals with solutions related to hair loss.

While the wig is usually used by those with total baldness or temporary hair loss, think for example of people undergoing chemotherapy, the skin patch, on the other hand, is essentially a non-surgical hair thickening and a solution that is used to cover some areas of the head.

Precisely for this reason it is more suitable for those with thinning hair and want to thicken their hair, while the wig is more suitable for those who have completely lost their hair.

There are two types of commercially available skin patches: standard patches and customized patches according to the customer's needs and cranial conformation.

The present invention relates to the second type of patch.

To create a customized skin patch, a first step of data acquisition on the customer is required, in particular regarding the cranial conformation of the area on which the skin patch is to be applied. This step is currently operated manually through the application on the skull of a gauze soaked in a hardening polymeric material which serves to create a mold of the client/patient's skull. This procedure involves the use of a large quantity of textile material (gauze), as well as the use of aggressive chemical products subject to controlled disposal. The subsequent production step of the skin patch is currently very little mechanized, just think of the process in which the micro-holes that reproduce the natural hair matrix must be made or the subsequent process in which the hair is applied in these holes currently operated manually. These methods have the disadvantage of requiring a large amount of time to be carried out.

Disadvantageously, in traditional skin patches the hair is injected and not knotted, making it less durable over time.

The object of the present patent application is therefore to provide a new method and a new system for:

• • the acquisition of data on the client/patient (in particular regarding the cranial conformation of the area on which the patch is to be applied) faster, less invasive, which does not require the use of disposable material, and consequent creation of a digital twin of the client/patient;
  • faster and more efficient skin patch production.

DESCRIPTION OF THE INVENTION

According to the present invention, a system and a method implemented for the customized production of skin patches are provided which effectively solve the above problems.

The method for customized production of skin patches can be divided into three main steps: mapping of the patient, preparation of the working base and hair application, and each of these macro-steps can be further divided into steps or sub-steps.

The first main step of patient mapping can be further divided into at least 7 steps:

• • 1. acquisition of the parameters: consisting in an analysis and definition of the patient scalp properties, like hair typology, color, density and aesthetic properties, and consequent identification of the affected skull area that needs to be covered by the skin patch. This step is very important because it allows you to find a customized setting for the skin patch;
  • 2. application of a transparent film on the patient head, in order to promote an improved acquisition of the skull shape and following delimitation by the operator of the area involved in the detection using a special kajal pencil;
  • 3. automatic detection of the cranial shape using a structured light 3D scanner. Advantageously, this operation makes it possible to best protect the patient's dignity and is more environmentally sustainable as it does not involve the use of materials such as cellophane films, hardening resins and related application tools, simplifying the work of the operator in charge of measurement. Structured light 3D scanners are 3D scanning systems that allow you to digitize objects in 3D, reconstructing their geometry through the projection of coded light patterns. A correct detection of the conformation of the skull is fundamental for the optimal result and a perfect adherence of the skin patch since the braincase varies from individual to individual. 3D scanning using structured light technology makes it possible to detect the surface of the skull together with the chromatic mapping—commonly called texture—useful for defining the affected areas through their chromatic differentiation. Advantageously, structured light scanning technology is safe and harmless to humans, which is why structured light 3D scanners may also be used to scan the human body for medical purposes. This detection step of the patient's cranial conformation has been advantageously automated by virtue of the use of the structured light 3D scanner which allows a considerable speeding up of this step compared to the currently used manual method which involves the use of gauze soaked in a hardening polymeric material. This process, in addition to the advantageous saving of time, has two further advantages: it causes less stress on the patient related to the application of chemical products on the skin; no textile materials and chemical products subject to controlled disposal are used with a consequent reduction of the environmental impact of the entire process;
  • 4. elaboration of a CAD model of the “work head”: starting from the raw detection data, the scanning allows to analyze and elaborate a parametric 3D model (CAD) through a special software that perfectly reflects the affected area of the patient. Advantageously, a digital copy (digital twin) of the patient is created which increases the accuracy and repeatability of the operations. The “work head” is a three-dimensional physical model that reproduces the exact shape of the patient's skull. It includes a cranial surface consistent with the acquired model and a connection base with an aspiration system placed in the part below the representation of the cranial surface. The connection base consists of a cylindrical profile integrating a thread preferably of the fine pitch “Withworth” type. The choice of this thread is very important as it has a very fine pitch and is used for joining pipes subjected to gaseous pressure which will be used in subsequent work steps. The very fine pitch allows, by virtue of the proximity of the various threads, to obtain a very strong connection. Coupled with a gasket, it allows withstanding high pressures. This construction of the work head is therefore advantageous since it is resistant to the suction pressure (hair suction described in the following step). A key feature of the work head is its internal cavity which allows connecting the holes of the follicular matrix located in the cranial surface with the connection base. This cavity will allow the hair to be inserted by suction, as described in a subsequent step;
  • 5. processing of the follicular matrix: once the modeling of the work head is completed, the operator processes the follicular matrix, consisting of special conical holes representing the distribution of the patient's hair follicles, in line with the data acquired during the parameter collection step. These holes have a conical shape suitable for receiving and containing the hair which will be applied in a subsequent step and have the function of sucking and retaining the hair through the connection to the suction system connected to the previously prepared connection base;
  • 6. preparation of a template through the production with 3D printing with SLA technology (Stereolithography);
  • 7. robotic micro-drilling of the hole matrix representing the follicular distribution. This robotic micro-drilling consists in the automated creation of a plurality of conical holes corresponding to the points previously identified with the follicular matrix, by means of a suitable electronically controlled articulated robotic arm. More precisely, for the implementation of the micro-drilling it will be necessary to use a numerical control machine capable of operating on finished semi-finished products with curved surfaces. Machining of curved surfaces using numerical control machines is feasible by virtue of the use of a special contact probe capable of detecting the profile in which the drilling operation will then be carried out.

More precisely, the process will be carried out as follows:

• • assembly of the template on the appropriate housing inside the numerical control machine;
  • profile detection by contact probe;
  • micro-drilling using a conical cutter.

Advantageously, the innovation of this process allows the creation of a high precision micro-drilling on an irregular surface.

The second main step is the preparation of the work base. First of all, the setting of the template for processing consists in the application of a polymeric film on the upper external surface of the same, i.e. in the area representing the cranial surface and the follicular matrix. The most suitable material for this application has been identified in compact elastic polyurethane.

Subsequently, the template is connected to the suction system through the appropriate threaded section with a simple rotation.

The third main step consists in the application of the hair which is divided into the following sub-steps:

• • the hair is divided by the operator into bundles of 5 mm to 50 mm, preferably 20 mm, each at the workstation and aligned at the base of the bundle. The operator can then proceed with the activation of the suction system to start the insertion;
  • once the suction system has been activated, the hair is brought near the suction holes. With a simple passage of the hair near the template, the conical holes present receive the hair inside them by inserting them into their appropriate profile;
  • once the aspiration of all the hair has been completed and all the holes in the template have been filled, the heating system is activated which brings the temperature of the polyurethane close to the melting point. The polymeric film, once heated, allows the hair to adhere to it by filling the gaps near the holes;
  • the system is progressively cooled by turning off the heating system to allow the polyurethane to solidify. The skin patch is now ready for application to the patient using known techniques.

Advantageously, this step too, automated by virtue of the suction process, is quicker and less alienating for the operator.

The advantages offered by the present invention are clear in the light of the above description and will be even clearer from the accompanying figures and the related detailed description.

DESCRIPTION OF THE FIGURES

The invention will hereinafter be described in at least a preferred embodiment thereof by way of non-limiting example with the aid of the accompanying figures, in which:

FIG. 1 shows a flowchart illustrating the three main steps of the custom skin patch manufacturing method: mapping of patient A; preparation of the work base B; application of hair C and the seven sub-steps of the first main step of mapping of patient A1-A7;

FIG. 2 shows the work head 1 formed by the connection base 2 and at the top the template 3 on which the polyurethane 9 is applied, under which the suction system 4 is positioned which attracts the hair 7 inside the micro-holes 6 which make up the follicular matrix 5;

FIG. 3 shows the skin patch 8 with the follicular matrix 5 and the hair 7;

FIG. 4 shows an enlargement of the follicular matrix 5 composed of conical micro-holes 6 inside which the hair 7 is fixed.

DETAILED DESCRIPTION OF THE INVENTION

The present invention will now be described purely by way of non-limiting or binding example with the aid of the figures, which illustrate some embodiments relative to the present inventive concept.

With reference to FIG. 1, it describes a method for the customized production of skin patches 8 which can be divided into three main steps: mapping of the patient; preparation of the work base; hair application 7.

• • a) Mapping of the patient: the aim of this step being that of collecting/acquiring all useful information and mapping the patient in order to create a digital copy of the same, that may be used in all production steps of the skin patch 8. The digital twin is nothing but the virtual replica of the patient's skull integrating shapes and features useful for the process. This process allows the conformation of the person's skull and its peculiarities to be analyzed with digital tools in a minimally invasive way and without the use of materials and techniques that involve invasive mechanical applications on the skin. The activity is carried out progressively through the collection of parameters, preliminary shaving and 3D scanning of the cranial conformation.

The first main step of patient mapping can be further divided into 7 steps:

• • acquisition of the parameters of the patient scalp properties, such as: hair 7 typology, color, density and aesthetic properties, and consequent identification of the affected skull area that needs to be covered by the skin patch 8. This step is very important because it allows you to find a customized setting for the skin patch 8;
  • a2) application of a transparent film on the patient head, in order to promote an improved acquisition of the skull shape during a detection using a 3D scanning, and subsequent delimitation—by an operator who uses a dedicated kajal pencil—of said area affected by said detection;
  • a3) automatic detection of the cranial conformation using a structured light 3D scanner: a correct detection of the conformation of the skull is fundamental for the optimal result and a perfect adherence of the skin patch since the braincase varies from individual to individual. The handheld scanning device that can be gripped with one hand is connected to a special PC and is oriented towards the patient's head and, projecting lines of light through a special emitter, detects their variation by interpreting the affected surface. This process has a total duration that can be estimated at five minutes;
  • a4) elaboration of a CAD model of the work head 1 through a special software which perfectly reflects the area of the patient involved. A digital copy (digital twin) of the patient is thus created which increases the accuracy and repeatability of the operations.
  • a5) Processing of a follicular matrix 5 consisting of special conical holes 6 representing the distribution of the patient's hair follicles, in line with the previously acquired parameters. These holes 6 have a conical shape capable of receiving and containing the hair 7 which will be applied in a subsequent step and have the function of retaining the hair 7 through the connection to a suction system 4 connected to the base of the work head 1 previously prepared;
  • a6) preparation of a template 3 through the production with 3D printing with SLA technology (Stereolithography). More precisely, SLA 3D printers use light-reactive resins. When stereolithography resins are exposed to light of a specific wavelength, short molecular chains join together, polymerizing the monomers and oligomers into solidified rigid or flexible geometries. Therefore, the file containing the 3D model is transferred to the printing device and the printer produces a template 3 through the solidification of a suitable photosensitive resin;
  • a7) robotic micro-drilling of the matrix 5 of holes 6 representing the follicular distribution. By means of a suitable electronically controlled articulated robotic arm, the holes 6 are made with a starting diameter preferably of 1 mm and a lower diameter preferably of 0.5 mm. More precisely, for the implementation of the micro-drilling it will be necessary to use a numerical control machine adapted to operate on finished semi-finished products with curved surfaces. Machining of curved surfaces using numerical control machines is feasible by virtue of the use of a special contact probe capable of detecting the profile in which the drilling operation will then be carried out. More precisely, the operation will be carried out as follows: assembly of the template 3 on the suitable housing inside the numerically controlled machine; profile detection by contact probe; start of the micro-drilling process using a conical cutter.
  • b) Preparation of the work base: setting of the template 3 for processing consisting in the application of a polymeric film on the upper external surface of the same, i.e. in the area representing the cranial surface and the follicular matrix 5, and subsequent connection to the aspiration system 4 via the appropriate threaded section with a simple rotation. Three features of the polymeric film have been identified: good mechanical resistance with a thickness preferably between 0.3 and 0.8 mm; good elasticity and flexibility for optimal adherence to the scalp; transparency for an aesthetic effect that is as natural as possible. The most suitable material for this application has been identified in compact elastic polyurethane. The application of the polyurethane takes place through automatic or manual spraying of the material. In order to avoid the clogging of the micro-holes 6, a special compressor will be connected to the template 3 which will push the air through the micro-holes 6 to clean them of any residual material. Subsequently, the template 3 is connected to the suction system 4 through the appropriate threaded section with a simple rotation. The device necessary for the suction 4 of the hair 7 through the micro-perforated template 3 can be described as follows: the template 3 is installed and connected firmly on a suitable work platform by means of a suitable fitting with Whitworth threaded cylinder (the work table will have preferably dimensions of about 1000 mm×2000 mm); the template 3 is connected to the suitable heating system by means of an electric resistance and to the suction pump 4; below the platform there is a suction pump 4 specially sized to obtain a vacuum capacity in average conditions. Specifically, the values to be obtained will preferably be between 3×103 Pa−1×10−1 Pa. The pump has an electromechanical actuator for switching it on and off. A special barometer 11 is installed between the pump and the template 3 which monitors the pump pressure.
  • c) Hair application 7 takes place by manual or automatic approach of the same to the template 3 connected to the suction system 4. First, the hair 7 is divided by the operator into bundles of 05 mm to 50 mm, preferably 20 mm, each at the workstation and aligned at the base of the bundle. The operator can proceed with the activation of the suction system 4 to start the insertion. Once the suction system 4 has been activated, the hair 7 is brought near the holes 6 manually or by means of a suitable robot. With a simple passage of the hair 7 in the vicinity of the template 3, the conical holes 6 present receive the hair 7 inside them, engaging them in their appropriate profile. Once the aspiration of all the hairs 7 has been completed and all the holes 6 of the template 3 have been filled, the heating system is activated which brings the temperature of the polyurethane close to the melting point. The polymeric film, once heated, allows the adhesion of the hair 7 to it by filling the gaps near the holes 6. The system is progressively cooled by turning off the heating system to allow the polyurethane to solidify. The skin patch 8 is now ready for application to the patient.

All the instrumentation used in the steps of the method just described constitutes the system for making skin patches 8, object of the present invention.

The invention is defined by the appended claims.

Finally, it is clear that modifications, additions or variants may be made to the invention described thus far which are apparent to those skilled in the art, without departing from the scope of protection that is provided by the appended claims.